The Recall Lawyers

A new study released in The Lancet, one of the world's leading medical journals, found metal-on-metal artificial hips have a higher fail rate than other types. The study lends weight to the growing concerns of the implants safety and actually prompted a call from researchers to ban the devices from the market.

Traditional hip implants combine a ceramic or metal ball with a plastic socket. Metal-on-Metal hips were developed as a more durable option to these traditional implants. However, this new study and the recall of Johnson & Johnson's DePuy metal-on-metal hips certainly suggest the risk to patient safety outweighs the benefits of durability. In fact, some critics argue the hips should never have been allowed on the market.

The comprehensive study found that patients with a metal-on-metal hip implant have a 6.2 percent chance of needing a replacement within the first five years. This revision rate is nearly three times greater than with the traditional implants. The research team from the University of Bristol in the United Kingdom said the results were unequivocal: "Metal-on-metal stemmed articulations give poor survival compared with other options and should not be implanted."

The attorneys of Jones Ward PLC represent clients from across the country in products liability cases, including those with a recalled DePuy hip implant. If you or someone you know has a DePuy ASR hip implant or any other failed hip replacement product and would like to speak to someone about a potential case, contact attorney Terrance Massey. You can reach him by phone at (502) 882-6000 or by email at tj@jonesward.com.

On January 4, 2012, the FDA announced that it is considering changing the classification of transvaginal mesh from a Class II to Class III medical device.

What is the difference between Class II and Class III?

A Class III device requires "an independent assessment of safety and effectiveness during a premarket review." Basically, a Class III drug goes through rigorous trials before it is approved by the FDA for use. A Class II device, on the other hand, may be exempt from this kind of testing or premarket review.

How did transvaginal mesh get approved by the FDA in the first place?

For most Class II devices, they are not required to go through premarket review because of the FDA's 510(k) submission process. This process allows drug companies to get their devices approved by the FDA by claiming that they are "substantially equivalent" to a device that has already been approved. 168 transvaginal mesh devices on the market became FDA approved through this process.

Was there any kind of testing of transvaginal mesh?

There were lab studies and animal studies that drug companies submitted to the FDA. There were no human studies.

If transvaginal mesh is reclassified from a Class II to Class III device, companies that make these devices will be required to go through postmarket surveillance studies. According to FDA policy, this process can take up to three years. It could have a very significant impact on some of the ongoing lawsuits brought by women and their spouses who have been injured by transvaginal mesh.

What is transvaginal mesh?

Transvaginal is mesh that is used in the vagina for certain surgeries to treat one of the following conditions:

• Pelvic Organ Prolapse (POP). For more information on POP, click http://www.the-recall-lawyers.com/2011/09/fda-to-hold-transvaginal-mesh.html#more
• Sudden Urinary Incontinence (SUI). This is a condition that occurs when a woman is unable to prevent urine from leaking from her urethra. There are many known causes, the most common of which is pregnancy. Multiple pregnancies may cause this condition to become permanent.

Continue reading "FDA Considers Requiring More Studies of Transvaginal Mesh" »

Following two days of meetings on transvaginal mesh, the FDA said it would require two makers of vaginal mesh, Johnson & Johnson and C.F. Bard Inc., to conduct clinical studies and present safety information on the use of mesh to treat Pelvic Organ Prolapse (POP).

The FDA had initially approved mesh under a summary proceeding requiring no preclinical testing. However, now at least seven deaths have been linked to its use. Problems caused by vaginal mesh have been described as extremely painful and include organ perforation, bleeding, and infection. Such complications may require corrective surgery.

Continue reading "FDA to Require Transvaginal Mesh Clinical Trials" »